BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2021780 · Received February 25, 2011

    Report

    Report Number
    1644487-2011-00358
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON'S OFFICE THAT A PULSE GENERATOR MODEL 103 WAS CURRENTLY DISABLED DUE TO A VBAT <EOS THRESHOLD. THE REPORTER WAS IN THE OPERATING ROOM AND SYSTEM DIAGNOSTICS WERE PERFORMED ON THE GENERATOR AS IT WAS TO BE IMPLANTED ON A PT AS INITIAL IMPLANT. SYSTEM DIAGNOSTICS WERE INDICATIVE OF EOS AND REPORTER INDICATED THAT ELECTROCAUTERY WAS USED ONCE GENERATOR ENTERED THE FIELD. THE MFR INFORMED THE CALLER THAT ANY ELECTRICAL CURRENT GOING THROUGH GENERATOR CAN CAUSE DAMAGE TO GENERATOR AND I ALSO INFORMED HER OF SAFETY ALERT LETTER INVOLVING ELECTROCAUTERY AND 103/104. THE REPORTED GENERATOR WAS RETURNED TO THE MFR AND IS CURRENTLY UNDERGOING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201565

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR